MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MICROMARK; BIOPSY SITE IDENTIFIER

Model Number C1535J

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

The micromark ii tissue marker tissue marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.One c1535 was received for investigation on 2/28/2017 and analyzed on 3/23/2017.Device was found to be in fair condition.Evidence of use in a procedure was present on the marker.Marker device is intact with the marker clip deployed.Marker clip was received in vial with breast tissue attached.Device functionality check was unable to be confirmed since the clip was already deployed.The device history records were reviewed and there were no non-conformances that would relate to this failure.Due to the discovery of the tissue, the reportability was reassessed against the result of the investigation.Following consultation with our medical director, due to the potential to cause or contribute to death or serious injury as a result of potential missed or lost tissue samples, pursuant to 21 cfr §803, this failure mode was determined to be a reportable malfunction.Thus, we are submitting this medwatch report.

Event Description

The (b)(4) affiliate reported that after completion of retrieving tissues, the doctor tried to deploy the clip.However the clip was not released.

• Brand Name: MICROMARK
• Type of Device: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 6513629
• MDR Text Key: 73463302
• Report Number: 3008492462-2017-00028
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: C1535J
• Device Catalogue Number: C1535
• Device Lot Number: F11524314D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1